MAUDE Adverse Event Report: Cordis US Corp MYNX CONTROL; Device, Hemostasis, Vascular

Catalog Number	MX6760
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, after prep, the user was in the process of inserting the atraumatic tip of a 6/7f mynx control vascular closure device (vcd) into the sheath hub, when the user noticed fraying of the proximal tip of the sealant housing with exposed sealant.A new device from the same lot was prepared and deployed without complication.The dvice was removed from table and new mynx control vascular closure device 6f/7f was deployed without any issues or complications.There was no reported patient injury.The device was removed from packaging by handle and prepped according to the instructions for use (ifu) standards by a trained user.The device was inspected for damage when removed from the package, and no damage to the packaging or device was noted at that time.The device never entered the sheath.A6f non-cordis sheath was used.The device was never inserted into the patient or deployed.Femoral artery suitability, including a vascular sheath introducer insertion angle of 30¿45 degrees, was verified on angiography.The vessel diameter was verified to be greater than or equal to 5 mm.There was no peripheral vascular disease (pvd) or calcium in the vicinity of the puncture site.The device will be returned for analysis.
Additional Manufacturer Narrative
Due to system limitations, section h6 required to input type of investigation, investigation findings, and investigation conclusions for an initial report.Pending additional information to complete investigation.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

• Brand Name: MYNX CONTROL
• Common Device Name: Device, Hemostasis, Vascular
• Manufacturer (Section D): Cordis US Corp; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): Cordis US Corp.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; santa clara, CA 95054 ; +1(786)313-8372
• MDR Report Key: 50754847
• Report Number: 3004939290-2026-01276
• Device Sequence Number: 15817690
• Product Code: MGB
• UDI-Device Identifier: 10862028000434
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P040044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MX6760
• Device Lot Number: 18591536
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/04/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: unknown sheath
• Patient Sex: Unknown